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Chemical Listed Effective November 27, 2015 as Known to the State of California to Cause Reproductive Toxicity: Topiramate

Effective November 27, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) is adding topiramate (CAS No. 97240-79-4) to the list of chemicals known to the state to cause reproductive toxicity (developmental endpoint) for purposes of Proposition 651.  

The listing of topiramate is based on a formal requirement by a state or federal agency that the chemical be identified or labeled as causing reproductive toxicity2 as provided under Proposition 65.  Topiramate has been identified or labeled to communicate a risk of reproductive harm (developmental toxicity endpoint) in accordance with formal requirements by the US Food and Drug Administration.  Regulations governing the listing of chemicals under the “formally required to be labeled or identified” mechanism are published in Title 27, California Code of Regulations, section 25902.

The documentation supporting OEHHA’s determination that topiramate meets the criteria for administrative listing is included in the Notice of Intent to List Topiramate, published in the October 2, 2015 issue of the California Regulatory Notice Register (Register 2015, No. 40-Z).  No public comments were received.

A complete, updated chemical list is published in this issue of the California Regulatory Notice Register and is available on the OEHHA website at www.oehha.ca.gov.

In summary, the following chemical is listed under Proposition 65 as known to the State to cause reproductive toxicity:

Chemical

CAS No.

Toxicological Endpoints

Listing Mechanism*

Topiramate

97240-79-4

Developmental toxicity

FR

Downloads

Footnotes and References

* Listing mechanism:  FR — “formally required to be labeled or identified” mechanism (Health and Safety Code section 25249.8(b)) and Title 27 Cal. Code of Regs., section 25902

1 The Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code section 25249.5 et seq.

2 See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25902